Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional) is a grant from the National Institute of Neurological Disorders and Stroke (NINDS) that funds small businesses to conduct rigorous clinical validation of candidate biomarkers for neurological and neuromuscular conditions.

Using the SBIR Fast Track (U44) cooperative agreement mechanism, the program supports projects where a candidate biomarker has already been identified and analytically validated, enabling researchers to establish clinical sensitivity and specificity consistent with FDA guidelines. Biomarker categories in scope include diagnostic, prognostic, pharmacodynamic, monitoring, and safety endpoints for the full age spectrum.

Eligible applicants are U.S.-based small businesses. Letters of intent are due 30 days prior to the application deadline.

Expired PAR-24-096: Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Neurological Disorders and Funding Opportunity Title Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional) U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Fast Track Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. January 14, 2025 - Notice of Change: Only BESH CT Applications Accepted in PAR-25-050, PAR-24-098, PAR-25-055, PAR-24-096. See Notice NOT-NS-25-009 .

April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 November 14, 2023 - Clarification of Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements. See Notice NOT-OD-24-029 .

June 12, 2023 - Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements­­. See NOT-OD-23-139 . February 23, 2023 - Notice of Change to Minimum Performance Standards for SBIR and STTR Applicants­­.

See NOT-OD-23-092 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity Research Project (Cooperative Agreements) Research Project (Cooperative Agreements) Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II See Section III.

3. Additional Information on Eligibility. Assistance Listing Number Notice of Funding Opportunity Purpose The purpose of this notice of funding opportunity (NOFO) is to enable clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions.

Specifically, the goal of this PAR is to enable the rigorous clinical validation of biomarker measurements within the clinical population of interest to establish the clinical sensitivity and specificity of the biomarker consistent with FDA guidelines.

This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. New Date November 17, 2025 per issuance of NOT-OD-26-006 .

Required Application Instructions It is critical that applicants follow the SBIR/STTR (B) Instructions in the How to Apply – Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description A biomarker is a defined characteristic that is measured as an indicator of a normal biological process, pathogenic process, or responses to an exposure or intervention, including therapeutic interventions. Biomarker modalities are diverse, and can include ‘omics, imaging, behavioral, digital and physiologic endpoints.

Because the measurement of the biomarker is integral to defining the biomarker, it is necessary to describe the biomarker in terms of its biological source or matrix, measurable features, and the analytic method used to measure it (“detection method”).

Biomarkers are critical to the discovery and development of therapeutics and can serve a variety of functions such as verifying therapeutic target engagement, improving trial design by patient stratification, and facilitating clinical care decisions.

Despite the active pace of discovery of novel biomarker candidates, few biomarkers progress beyond discovery to the robust analytical and clinical validation needed for use in Phase II and Phase III clinical trials.

Thus, there is a critical need to advance validation of biomarkers to improve public health, particularly for disorders of the nervous system where advancing therapeutics from discovery to the market are notoriously challenging. Validation of biomarkers for all neurological and neuromuscular disorders within NINDS’ mission are within scope and may include a context of use focused on any part of the age spectrum.

This NOFO is intended to address the gap in biomarker validation by encouraging rigorous clinical validation of the biomarker detection method for one or two specified context(s) of use. Definitions of terms used in this NOFO : Context of Use (COU): A statement that fully and clearly describes the way the biomarker is expected to be used.

The COU should include the biomarker category (susceptibility/risk, diagnostic, monitoring, prognostic, predictive, pharmacodynamic/response, or safety), the modality, method of detection, and clinical population characteristics. Context of use statements are discussed extensively in the Framework for Defining Evidentiary Criteria for Biomarker Qualification developed by the Biomarkers Consortium: https://fnih.

org/sites/default/files/final/pdf/Evidentiary%20Criteria%20Framework%20Final%20Version%20Oct%2020%202016. pdf Concept: In a regulatory context, the concept is the aspect of an individual’s clinical, biological, physical, or functional state, or experience that the assessment is intended to indicate or reflect. Detection method: The method(s) used for measuring the biomarker(s).

Analytical Validation: A process to establish that the performance characteristics of a test, tool, or instrument are acceptable in terms of its sensitivity, specificity, accuracy, precision, and other relevant performance characteristics using a specified technical protocol (which may include specimen collection, handling and storage procedures).

This is validation of the test’s, tool’s, or instrument’s technical performance to measure the biomarker(s) of interest. Clinical Validation: A process to establish that the test, tool, or instrument acceptably identifies, measures or predicts the concept of interest.

Clinical validation establishes the data needed to reach conclusions or interpret the results of the biomarker(s) readout, and the level of confidence for these interpretations. Composite biomarkers/biomarker signatures: when more than one biomarker is being validated for the same context of use (e.g., a panel of biomarkers, or set of features used as a composite indicator).

Clinical Outcome Assessment (COA): a measure that describes or reflects how a patient feels, functions, or survives (includes patient-reported outcomes, observer-reported outcomes, clinician-reported outcomes, and performance outcomes).

Digital Biomarker: The term “digital biomarker” is widely used to mean assessments that include both biological processes (such as changes in heart rate or galvanic skin response) as well as performance assessments (such as measurements derived from accelerometers).

Both digital biomarkers and digital performance assessment are within scope of this NOFO, however other patient-reported outcomes, observer-reported outcomes, and clinician reported outcomes are not within scope. Biomarker categories as defined in the Biomarkers, EndpointS, and Other Tools (BEST) Resources (https://www. ncbi.

nlm. nih. gov/books/NBK338448/) include: Monitoring biomarkers to track the success of a therapeutic intervention or the disease progression Diagnostic biomarkers used to detect or confirm presence of a disease or condition of interest or to identify individuals with a subtype of the disease.

Prognostic biomarkers for predicting outcomes Predictive biomarkers for differentiating individuals based on favorable or unfavorable effect from a therapeutic or other intervention Pharmacodynamic/response biomarker that indicates biologic activity of a medical product or environmental agent without necessarily drawing conclusions about efficacy or disease outcome or necessarily linking this activity to an established mechanism of action.

Safety biomarkers to indicate the likelihood, presence, or extent of an adverse effect Susceptibility/risk biomarkers that indicate the potential for developing a disease or medical condition in an individual who does not currently have a clinically apparent disease. This NOFO supports research to conduct clinical validation of a biomarker or biomarker signature or composite biomarker for one or two specified context(s) of use.

For the purpose of this NOFO, the term “Biomarker(s)” will be used interchangeably with biomarker signature and composite biomarkers.

Premise for the utility of the biomarker(s) should include evidence that the biomarker(s) has undergone preliminary testing in an appropriate clinical population, using either prospective or retrospective data or samples, and shows sufficient clinical sensitivity and specificity and/or association with the biological concept of interest to warrant additional investment.

In addition, applications to this NOFO should include evidence that the detection method for the biomarker has already been developed and subjected to initial evaluation of precision and analytical sensitivity.

This NOFO supports analytical validation research that plans to optimize and standardize the detection method and rigorously test the analytic and pre-analytic variables to evaluate and reduce sources of variability when measuring the biomarker.

Earlier stage research that still needs to conduct clinical proof of concept studies to establish the relationship between candidate biomarkers with a concept of interest (with or without detection method development) should consider applying to the companion NOFO, PAR-22-089 “Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders”.

Alternatively, studies that are seeking to conduct final analytical validation research should consider the companion NOFO “Clinical Validation of Biomarkers for Neurological and Neuromuscular conditions”.

This funding opportunity uses a cooperative agreement, milestone driven mechanism that enables significant input from NIH staff to assist investigators with preparing and evaluating their analytical validation strategy through milestone negotiation.

The Analytical Validation NOFOs and companion Clinical Validation NOFOs are designed to help gather the data package needed for clinical trial readiness and may be used to support a submission to the FDA’s Biomarker Qualification Submission or to the FDA’s Center for Devices and Radiological Health, if applicable. For more information on the Biomarker Qualification program see: https://www. fda.

gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/BiomarkerQualificationProgram/default. htm Application Characteristics One or two clearly defined context(s) of use A strong justification for the clinical and/or research need of the biomarker(s) and the detection method for the context(s) of use.

Justification of feasibility, including potential added clinical burden and cost, of incorporating the biomarker into clinical trials or clinical practice (as appropriate for the context(s) of use). A clear and well justified study design and statistical design(s) A direct comparison to existing biomarkers or clinical outcome assessments used for the same COU, if applicable.

A multi-site design to demonstrate reliable results across sites in a sufficiently representative cohort, or a strong scientific justification why only one site is needed. Evidence of scientific rigor in the supporting literature underlying the premise, the preliminary data, as well as in the research strategy, design, execution, and interpretation of the proposed studies.

A clear and feasible timeline with quantitative annual milestones that demonstrate continued feasibility and progress towards the project’s success (see section IV “Other Project Information”) A team management plan (see section IV “Other Project Information”) If applicable, an Intellectual Property (IP) plan (see section IV “Other Project Information”) Clinical Validation should include the following metrics with use of FDA guidance standards appropriate for the Context of Use Sensitivity and specificity of the biomarker within the Context of Use, including methods for binary and/or continuous analysis.

Area Under the Curve (AUC) as determined by Receiver Operator Characteristic (ROC) Analysis Estimation of the prevalence of the marker within subjects or patients for the intended clinical context. Establishing the appropriate thresholds or reference ranges for the biomarker for decision making within the context of use.

Positive Predictive Value (the probability that a positive screening test result is true, taking into account the prevalence of the disease or condition in the population being measured). Negative Predictive Value (the probability that a negative screening test result is true, taking into account the prevalence of the disease or condition in the population being measured).

Collaborations and Consultants Multidisciplinary collaboration among scientific investigators, clinical scientists, disease/biology matter experts, statisticians, regulatory expertise, and other academic/industry experts relevant to the context of use in the application as well as clinical and laboratory staff are an integral part of the application.

Investigators are also encouraged to form collaborations/obtain consultants with individuals knowledgeable in relevant regulatory processes and/or statisticians knowledgeable in clinical trial design. Leveraging Existing Resources Where applicable, applicants are encouraged to leverage existing research resources for their studies.

Such resources may include clinical biospecimen samples from the NINDS Human Biospecimen and Data Repository (BioSEND; https://biosend. org/ ) or other existing biospecimen, imaging and data repositories. Leveraging the resources of ongoing clinical trials or clinical studies supported through other Federal or private funds is also encouraged.

Rigor, Reproducibility, Data Sharing and Intellectual Property NINDS, as part of NIH, strives for rigor and transparency in all research it funds. For this reason, NINDS explicitly emphasizes the NIH application instructions related to rigor and transparency ( https://grants. nih.

gov/policy/reproducibility/guidance. htm ) and provides additional guidance to the scientific community ( https://www. ninds.

nih. gov/Funding/grant_policy ). For example, the biological rationale for the proposed experiments must be based on rigorous and robust supporting data, which means that data should be collected via methods that minimize the risk of bias and be reported in a transparent manner.

If previously published or preliminary studies do not meet these standards, applicants should address how the current study design addresses the deficiencies in rigor and transparency. Proposed experiments should likewise be designed in a manner that minimizes the risk of bias and ensures validity of experimental results.

To improve reproducibility and community uptake, investigators are generally expected to share code/scripts, analytic tools/statistical models, protocols/processes and metadata before the end of the project’s period of performance.

If there is a plan to commercialize aspects of the project such as analytic software, applicants should consult with their tech transfer office when developing the data sharing plan and intellectual property plan. Budgets should reflect any costs associated with these efforts. Information on many available NIH supported or frequently used repositories is available at: https://www.

nlm. nih. gov/NIHbmic/nih_data_sharing_repositories.

html Applicants collecting biofluid samples from prospectively enrolled study participants are encouraged to share samples through the NINDS biomarker repository, BioSEND ( https://biosend. org/ ) to provide the broader scientific community with a data resource for hypothesis generation and test validation. Applicants should contact BioSEND to incorporate sharing plans and cost in their application.

Pre-Application Consultation Applicants are strongly encouraged to consult with NINDS Program Staff early on during the planning for an application. This early contact will provide an opportunity to discuss and clarify NINDS policies and guidelines, including the scope of the project relative to the NINDS mission and intent of this NOFO.

These discussions can also provide any needed clarification regarding development of an appropriate timeline and milestone plan and guidance for requesting approval of budgets that exceed $500,000 direct cost in any given year. Applications within the top scoring meritorious range will be considered for funding.

Within that range, priority may be placed on applications that fill a critical program gap to ensure biomarker development that is reflective of the breadth of disorders and conditions within NINDS’s mission.

Additionally, priority will be given to biomarkers that: 1) address an unmet medical need, 2) are supported by a strong biological rationale, 3) include a carefully designed plan for performance evaluation, 4) include a plan for standardization of samples and data collection for use in validation and 5) provide a strong justification for the utility of the biomarker in the clinical setting or for use in clinical trial design.

Applications Not Responsive to this NOFO Non-responsive studies include: clinical trials or clinical research where the primary intent is to develop therapeutic agents or devices, clinical trials or clinical research to evaluate a therapeutic agent or device’s clinical safety, efficacy, effectiveness, and/or clinical management, pre-clinical research using animal models, applications where the primary intent is to validate clinical outcome assessments rather than biomarkers, applications that do not specify the context(s) of use, applications that do not include milestones, applications that are not within the NINDS mission STTR applications will not be accepted.

Non-responsive applications will be administratively withdrawn without review See Section VIII. Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

See Section VI. 2 for additional information about the substantial involvement for this NOFO. Application Types Allowed Resubmission (All Phases) New (Fast-Track SBIR Only) The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed for the NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s) Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Budgets up to $700,000 total costs per year for Phase I and up to $1,500,000 total costs per year for Phase II may be requested. Durations up to 2 years for Phase I and up to 3 years for Phase II may be requested. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria: 1.

Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; 2.

Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; i. SBIR and STTR.

Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), an Indian tribe, ANC or NHO (or a wholly owned business entity of such tribe, ANC or NHO), or any combination of these; OR ii.

SBIR-only. Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these.

No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern, unless that single venture capital operating company, hedge fund , or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States; OR iii. SBIR and STTR.

Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121. 705(b) concerning registration and proposal requirements.

4. Has, including its affiliates, not more than 500 employees. SBIR and STTR.

Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), an Indian tribe, ANC or NHO (or a wholly owned business entity of such tribe, ANC or NHO), or any combination of these; OR SBIR-only.

Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these.

No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern, unless that single venture capital operating company, hedge fund , or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States; OR SBIR and STTR.

Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121. 705(b) concerning registration and proposal requirements.

If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.

If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner. If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner. Hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C.

1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State. Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.

Private equity firm has the meaning given the term “private equity fund” in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.

Venture capital operating company means an entity described in § 121. 103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.

ANC means Alaska Native Corporation. NHO means Native Hawaiian Organization. SBCs must also meet the other regulatory requirements found in 13 C.

F. R. Part 121.

Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq. , are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.

Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.

Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program.

Performance Benchmark Requirements Phase I to Phase II Transition Rate Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022.

The benchmark establishes a minimum number of Phase II awards the company must have received relative to a given number of Phase I awards received during the 5-fiscal year time period.

The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently completed year.

The Transition Rate requirement, agreed upon and established by all 11 SBIR agencies, was published for public comment in a Federal Register Notice on October 16, 2012 (77 FR 63410) and amended on May 23, 2013 (78 FR 30951).

For SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0. 25 will not be eligible to apply for a Phase I, Fast-Track, or Direct Phase II (if available) award for a period of one year from the date of the application submission.

This requirement does not apply to companies that have received 20 or fewer Phase I awards over the prior 5-fiscal year period. For application deadlines that fall on or after April 5, 2023: For SBIR and STTR Phase I applicants that have received more than 50 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0.

5 will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase I awards over the 5-fiscalyear period. On June 1 of each year, SBA will identify the companies that fail to meet minimum performance requirements.

SBA calculates individual company Phase I to Phase II Transition Rates using SBIR and STTR award information across all federal agencies. SBA will notify companies and the relevant officials at the participating agencies. More information on the Phase I to Phase II Transition Rate requirement is available at SBIR.

gov. Phase II to Commercialization Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Programs are implementing the Phase II to Commercialization Rate benchmark for Phase I applicants, as required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022.

The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 ( 78 FR 48537 ), with a reopening of the comment period published on September 26, 2013 (78 FR 59410).

For companies that have received more than 15 Phase II awards from all agencies over the past 10 fiscal years (excluding the two most recently completed fiscal year): Companies that meet this criterion must show an average of at least $100,000 in revenues and/or investments per Phase II award or at least 0. 15 (15%) patents per Phase II award resulting from these awards during the past 10- fiscal year period.

Applicants that fail this benchmark will not be eligible to apply for New Phase I, Fast-track or Direct Phase II (if applicable) awards for a period of one year. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently completed fiscal years.

For application deadlines that fall on or after April 5, 2023: For companies that have received more than 50 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $250,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period.

Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently completed fiscal years.

For application deadlines that fall on or after April 5, 2023: For companies that have received more than 100 Phase II awards from all agencies over the past 10-fiscalyears (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $450,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period.

Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 100 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently completed fiscal years.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants